Bluebird Closes In On First Approval For Neurodegenerative Disease Gene Therapy
The EU is set to be the first market to approve bluebird bio’s one-time gene therapy for cerebral adrenoleukodystrophy.
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Bluebird Exits Europe, Casting Clouds Over Gene Therapy Commercial Effort
The company will prioritize US market for gene therapies; FDA also placed eli-cel for CALD on clinical hold following a case of MDS.
EU Accelerated Assessment Tracker
Novartis is one of the latest companies to fail in its attempt to have a marketing authorization application fast-tracked at the European Medicines Agency. There was better news for BioMarin.
EU CHMP Opinions and MAA Updates
This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the European Union, and updates on EU marketing authorization changes recommended by the CHMP.